Companion diagnostics are used to guide therapy decisions: which patient would benefit from a drug and, conversely, which drug should not be administered to certain patients. More than 30 CDx tests have been approved by the FDA, and nearly 100 more tests are in clinical trials. Frost & Sullivan has profiled some of the more active companies in the CDx market.
The medical lexicon often struggles to keep up with the pace of innovation in the health care space. The term “personalized medicine,” for instance, was initially conceived to describe the practice of tailoring treatments to individuals rather than prescribe a one-size-fits-all approach. However, the vastness of the term “personalized” failed to capture specific approaches to do so. In fact, commentators have wryly noted that therapies and medications have been personalized since at least the time of Hippocrates.
The U.S. National Institutes of Health describes precision medicine as the practice of designing unique therapies, taking into account “the variability in genes, environment, and lifestyle for each person.” Of these, the role that genetics plays in determining therapies is of paramount importance to doctors. In fact, an entire field of study—pharmacogenetics—has emerged in the last decade to better understand the effect that genes have on a patient’s response to drugs. The success of the Human Genome Project has paved the way for faster and more whole genome sequencing services, which has increased the understanding of genes and their correlation with diseases. Today, companion diagnostics, abbreviated as CDx, are used to guide therapy decisions: which patient would benefit from a drug and, conversely, which drug should not be administered to certain patients.
CDx are tests that detect specific genetic markers, which inform clinical decisions. For example, the genes BRCA1 and BRCA2 are biomarkers for breast cancer; any mutation of these genes would impact therapeutic interventions. A CDx test, such as Myriad Genetics’ BRACAnalysis Diagnostic System, is used to help oncologists decide which breast cancer patient would respond favorably to a certain drug. Frost & Sullivan estimates the global CDx and related targeted therapy market to be worth more than $35 billion as of 2018. An indication of its growing importance can be gauged by the growth projections that this market will more than double in the next 6 years to reach $75 billion by 2024. Other emerging technologies in the precision medicine market, such as the use of molecular diagnostics and molecular imaging, will propel the precision medicine market to well above $100 billion by 2024.
More than 30 CDx tests have been approved by the U.S. Food and Drug Administration (FDA), and nearly 100 more tests are in clinical trials. Breast and lung cancers account for more than 50% of the disease states that are being examined, but non-oncological diseases such as HIV/AIDS, hepatitis and cystic fibrosis are also being studied. Frost & Sullivan has profiled some of the more active companies in the CDx market.
Myriad Genetics (Salt Lake City, Utah)
Myriad Genetics’ BRACAnalysis CDx is an FDA-approved test to determine whether breast cancer patients would likely respond to treatments involving PARP inhibitors. PARP1 is a protein that repairs kinks or breaks in DNA. Inhibiting a PARP protein will inhibit repair of the DNA in cells, causing them to die. This is the mechanism of action of PARP inhibitors, and they are often used to stall the proliferation of cancer cells by preventing DNA repair. The BRACAnalysis test is used to study the nature of BRCA mutation and decide whether a therapy involving the PARP inhibitor drugs Lynparza and Zejula are likely to be successful.
Abbott Laboratories (Abbott Park, Ill.)
In August 2017, Abbott announced that the FDA approved its RealTime IDH2 Assay to be used on patients with acute myeloid leukemia (AML) with IDH2 mutations who could benefit from a therapy called Idhifa. Idhifa was developed by New Jersey-based Celegene. It works by inhibiting the IDH2 enzyme, which is responsible for the growth of immature blood cells. The prognosis is especially poor for AML patients who suffer a relapse. Abbott’s CDx test was used to identify IDH2 mutations in nearly 200 patients with relapsed AML, and within 6 months of this test and administering Idhifa treatment, extremely positive results were noted: nearly 25% of the patients had no signs of cancer after the treatment, and more than 33% did not require blood transfusions as they did at the beginning of the study, indicating improvement.
Foundation Medicine, Inc. (Cambridge, Mass.)
Foundation Medicine secured a valuable regulatory clearance from the FDA in late 2017, according to which the company’s flagship CDx platform, FoundationOne CDx, can be used as a comprehensive genomic profiling assay for all solid tumors. The first-of-its-kind test can assess mutations in as many as 324 genes that are known to cause—or have close association with— certain cancer types. This broad-based approval makes it suitable to detect solid tumors associated with non-small cell lung cancer, melanoma and colorectal cancer, to name a few.
Following this regulatory approval, Foundation Medicine announced partnerships with leading pharmaceutical companies to develop and commercialize specific CDx products for various cancer types. In early 2018, Pfizer and Foundation announced a partnership to develop CDx tests in alignment with Pfizer’s existing portfolio of oncology drugs. Foundation has similar partnerships with Novartis and Johnson & Johnson.
The Road Ahead
Foundation’s broad-based biomarker test has already given a teaser of the rapid scalability of genomic testing. Added to this is the omnipresence of smartphones and other electronic gadgets, which has made capturing and quantifying physiological and lifestyle information easier. As knowledge of genetic, molecular and other biomarkers increases, the focus will shift from the lab to the computer. Big Data management and advanced analytics using artificial intelligence will play a big role in understanding disease causes, progressions, and the most appropriate and effective way to combat them.
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